FDA 510(k) Application Details - K083370

Device Classification Name	More FDA Info for this Device
510(K) Number	K083370
Device Name	D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006
Applicant	ARTEGRAFT, INC. 220 NORTH CENTER DR. NORTH BRUNSWICK, NJ 08902 US Other 510(k) Applications for this Company
Contact	LAURENCE A POTTER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2008
Decision Date	12/12/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review